Abbott Jubilant Over Fda Award

Test Gets 1st License In Aids Fight

March 04, 1985|By Michael L. Millenson.

Don`t kid yourself--Goliath likes to win a few, too.

Officials of Abbott Laboratories were jubilant Saturday after the North Chicago-based firm was awarded the first government license to produce a diagnostic test to screen blood for acquired immune deficiency syndrome

(AIDS).

Company scientists and top brass rose in predawn darkness to hop a corporate plane to Washington for a press conference featuring Margaret Heckler, secretary of health and human services, and Frank Young, commissioner of the Food and Drug Administration. The ceremony capped a competition that began last May, when the government gave a sample of the newly-isolated virus for AIDS, HTLV-III, to five companies and promised expedited approval for a test to spot HTLV-III antibodies.

Abbott earned a comfortable $402.6 million last year on sales of $3.1 billion and was the nation`s leading maker of diagnostic products, but the AIDS test victory was no less sweet for that.

In phone interviews Saturday, company officials took particular pleasure in pointing out that they had beaten competitors said to be more agile.

``We get hammered so much (with the accusation) that the smaller biotechnology companies are faster moving than the big multinational companies,`` said Jack W. Schuler, the Abbott executive vice president who oversees diagnostics. ``We`re feeling real good about ourselves.``

Added Robert A. Schoellhorn, Abbott`s chairman and chief executive officer: ``We are an entrepreneurial company. We are not a small biotechnology company.``

Entrepreneurial merit notwithstanding, Abbott`s size means that the economic impact of the AIDS test on the company will not be great by itself. The FDA estimates that 1.6 million AIDS tests will be needed monthly at blood centers. An undetermined number of tests will also be given at ``alternative sites`` to high-risk individuals who wish to see if they have AIDS antibodies without having to donate blood and risk contaminating the public blood supply. Peter Drake, an analyst at Kidder, Peabody & Co., puts the size of the U.S. market for the AIDS diagnostic test at $90 million. Abbott won`t give its own estimate, but officals say they see the European market eventually being the same size as the U.S. market. About 60 percent of the total international market will develop almost immediately, they say, adding that the company has urgent requests for the AIDS test from West Germany, Great Britain, Belgium, Canada and Australia.

Abbott will also have competition quickly. Government officials say two other companies could be approved to market the AIDS test within a week. Sources familiar with the process expect those to be Electro-Nucleonics Inc. and Litton Bionetics Inc. Lagging behind is a partnership of Biotech Research Laboratories and E.I. du Pont de Nemours & Co., followed by a partnership of Deerfield-based Baxter Travenol Laboratories Inc. and Genentech Inc.

Abbott officials acknowledge that being first to the AIDS test market has other advantages. The blood banks that will test for AIDS also test for hepatitis B, a market almost as large and one that Abbott dominates. The next major competitor in that market is Electro-Nucleonics, which will also be in the AIDS test market.

``In the chess game we`re playing against other players, it (the AIDS test approval) gets significant. It`s good symbolically,`` Schuler said.

``There`s a pull-through effect (to other products). If somebody else had done this, what would the impact have been on Abbott?``

The AIDS test detects antibodies that show that a person has been exposed to AIDS. However, exposure to the virus does not necessarily mean that a person will develop an infection. There have been 4,017 deaths in this country from the 8,314 cases of AIDS reported since 1981, health officials say. Of those cases, 116 people, including 14 children, have died from AIDS contracted from the transfusion of contaminated blood.

According to Schuler, Abbott has spent between $50 million and $100 million on hepatitis and AIDS research over the last 10 years.